Class II U.S. Food and Drug Administration

CooperVision, Inc. Brand Name: Pearle Vision 1 day Product Name: Contact Lens Model/ recall: A small number of lenses within the affected lot are of the incorrect power

Recall published 25 days ago

A small number of lenses within the affected lot are of the incorrect power.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: A small number of lenses within the affected lot are of the incorrect power.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3248-2026
Published
September 30, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
CooperVision, Inc.
Product type
Medical devices
Units affected
3060
Distribution
Nationwide
Made in
United States
Lot / code info
Pearle Vision 1 day; Carton Lot # 11727620152030; Blister Lot # CB132348;
UPC codes
11727620152030

Products covered by this recall

Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 11727620152030

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 11727620152030
  • CB132348

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

CooperVision, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: CooperVision, Inc. — 180 Thruway Park Dr, West Henrietta, NY, 14586-9798

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was CooperVision, Inc. medical devices recalled?

A small number of lenses within the affected lot are of the incorrect power. A small number of lenses within the affected lot are of the incorrect power.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 11727620152030; lot code 11727620152030, CB132348. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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